4 mg/mL for
Intravenous Injection
DESCRIPTION:
Dexamethasone Sodium Phosphate (DSP) is a salt of dexamethasone, a
synthetic corticosteroid which possesses glucocorticoid activity. DSP is
a white or slightly yellow crystalline powder which is particularly
suitable for intravenous administration because it is highly water
soluble. Each mL of sterile aqueous solution contains: Dexamethasone
sodium phosphate, 4 mg; sodium citrate, 10 mg; sodium bisulfite, 2 mg;
benzyl alcohol, 1.5%; sodium hydroxide and/or hydrochloric acid to
adjust pH; water for injection, q.s.
ACTIONS:
Dexamethasone as a steroid is equivalent in potency to some established
steroids and considerably more potent than others. In the case of the
dog, dexamethasone is approximately equivalent in dosage to prednisone,
but about 30 to 40 times more potent than prednisolone. DSP is
especially well suited for intravenous use in situations requiring a
rapid and intense glucocorticoid and/or anti-inflammatory effect.
WARNING:
Clinical and
experimental data have demonstrated that corticosteroids administered
orally or parenterally to animals may induce the first stage of
parturition when administered during the last trimester of pregnancy and
may precipitate premature parturition followed by dystocia, fetal death,
retained placenta and metritis. Additionally, corticosteroids
administered in dogs, rabbits, and rodents during pregnancy have
resulted in cleft palate in offspring. Corticosteroids administered to
dogs during pregnancy have also resulted in other congenital anomalies,
including deformed forelegs.
INDICATIONS:
Dexamethasone sodium phosphate is indicated for use as an
anti-inflammatory and/or glucocorticoid agent in conditions such as
acute arthritis.
DSP may be
used as supportive therapy in non-specific dermatoses such as summer
eczema and atopy, provided proper therapy is also instituted to correct
the cause of the underlying dermatosis. It may also be used prior to or
after surgery to enhance recovery of poor surgical risks, provided that
it is used in conjunction with full antibiotic coverage.
CONTRAINDICATIONS: Do
not use in viral infections. Except when used for emergency therapy, DSP
is contraindicated in animals with tuberculosis, chronic nephritis,
Cushings’ disease and peptic ulcers. Existence of congestive heart
failure, osteoporosis and diabetes are relative contraindications.
When
administered in the presence of infections, appropriate antibacterial
agents should also be administered and continued for at least 3 days
after discontinuance of the steroid.
PRECAUTIONS: Because of
the anti-inflammatory action of corticosteroids, signs of infection may
be hidden. It may therefore be necessary to stop treatment until
diagnosis is made. Overdosage of some glucocorticoids may result in
sodium and fluid retention, potassium loss, and weight gains.
In infections
characterized by overwhelming toxicity, DSP therapy in conjunction with
indicated antibacterial therapy is effective in reducing mortality and
morbidity. It is essential that the causative organism be known and an
effective anti-bacterial agent be administered concurrently. The
injudicious use of adrenal hormones in animals with infections can be
hazardous.
Use of
corticosteroids, depending on dose duration and specific steroid, may
result in inhibition of endogenous steroid production following drug
withdrawal. In patients presently receiving or recently withdrawn from
systemic steroid treatments, therapy with a rapid acting corticosteroid
should be considered in unusually stressful situations.
ADVERSE
REACTIONS: The
therapeutic use of DSP is unlikely to cause undesired accentuation of
metabolic effects. However, if continued corticosteroid therapy is
anticipated, a high protein intake should be provided to keep the animal
in positive nitrogen balance. A retardant effect on wound healing should
be considered when it is used in conjunction with surgery. Euphoria, or
an improvement of attitude, and increased appetite are the usual
manifestations. The intra-articular injection in leg injuries in the
horse may lead to osseous metaplasia.
Side reactions
such as glycosuria, hyperglycemia, diarrhea, polydipsia and polyuria
have been observed in some species.
·
Elevated levels of
SGPT and SAP
·
Vomiting and diarrhea
(occasionally bloody).
·
Cushing's syndrome in
dogs has been reported in association with prolonged or repeated steroid
therapy.
·
Corticosteroids
reportedly cause laminitis in horses.
DOSAGE AND
ADMINISTRATION: For
intravenous use only
DOGS -
0.25 to 1 mg intravenously as the initial dosage. (Based on 3 mg per mL
of dexamethasone). The dose may be repeated for three to five days or
until a response is noted.
HORSES -
2.5 to 5 mg intravenously. (Based on 3 mg per mL of dexamethasone.) If
permanent corticosteroid effect is required, oral therapy with
dexamethasone may be substituted. When therapy is to be withdrawn after
prolonged corticosteroid administration, the daily dose should be
reduced gradually over a number of days, in a stepwise fashion.
HOW
SUPPLIED: Dexamethasone
Sodium Phosphate Injection is supplied in 100 and 30 mL vials containing
4 mg of dexamethasone sodium phosphate per mL. (Equivalent to 3 mg per
mL of dexamethasone.)
Store
between 15°C and 30°C (59°F and 86°F).
CAUTION:
Federal law restricts
this drug to use by or on the order of a licensed veterinarian.